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Atomoxetine for ADHD-Related Insomnia in Children
Phase 4
Waitlist Available
Led By Judith Owens, MD, MPH
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is examining the effects of atomoxetine on ADHD-related insomnia in children. Atomoxetine is a non-stimulant drug used to treat ADHD, and there is evidence that it may also have a positive effect on sleep in children with ADHD. The trial will last for four weeks.
Who is the study for?
This trial is for boys and girls aged 6-17 with ADHD who have trouble falling or staying asleep, which their caregivers also see as a problem. They must not be affected by other sleep disorders like apnea, severe chronic illnesses, or use sedating/alertness-enhancing drugs regularly. Previous non-response to atomoxetine disqualifies them.Check my eligibility
What is being tested?
The study tests if atomoxetine (Strattera®), a non-stimulant ADHD medication, can help improve sleep in children with ADHD-related insomnia. Participants will randomly receive either atomoxetine or a placebo for four weeks to compare the effects on sleep difficulties.See study design
What are the potential side effects?
Atomoxetine may cause side effects such as stomach upset, decreased appetite, nausea, dizziness, mood swings and possibly affect growth rate in children. It's important to monitor any changes closely during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mean sleep onset latency
parent and child-reported evening settling difficulties
Secondary outcome measures
ADHD symptom improvement
Daytime Somnolence
executive functions and functional outcomes/quality of life
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Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,524 Total Patients Enrolled
64 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
86,806 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
66,971 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
66 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Judith Owens, MD, MPHPrincipal InvestigatorRhode Island Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child aged 6-17 and I speak English.I tried atomoxetine at the right dose and for the right length of time, but it didn't work for me.I have a diagnosed sleep disorder like sleep apnea or restless legs.My difficulty falling asleep is not just because of stimulant medication.I have trouble falling or staying asleep, and it's not just because of medication.The child has trouble falling asleep or staying asleep, and it's a concern for them or their caregiver.You have been diagnosed with Attention-Deficit/Hyperactivity Disorder according to specific guidelines.I or my child has trouble falling or staying asleep, not caused by medication.I have a long-term health condition like diabetes or severe depression.I regularly use medications that affect my sleep or wakefulness.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period still open for this study?
"This clinical trial, first posted in November 1st 2005 and last updated on July 5th 2006, is no longer enlisting patients. However, 377 other studies are presently recruiting participants."
Answered by AI
Does the eligibility requirement for this medical study include individuals aged 40 and above?
"The age restrictions for this trial have been explicitly outlined in the eligibility criteria, with a lower bound of 6 years and an upper boundary of 17."
Answered by AI
What level of risk do patients assume when undergoing this procedure?
"With the treatment having reached Phase 4 of clinical trials, there is ample evidence that it is safe and thus received a rating of 3."
Answered by AI
What criteria must a participant satisfy to be accepted into this research program?
"This clinical trial is recruiting 36 people with attention deficit hyperactivity disorder (ADHD) aged between 6 and 17 years old."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Rhode Island Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
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